Rethinking the Components, Coordination, and Management of the U.S. Environmental Protection Agency Laboratories (2014)

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Introduction

COMMITTEE’S STATEMENT OF TASK

The US Environmental Protection Agency (EPA) is undertaking an integrated evaluation of its laboratories for the purposes of strengthening the management, effectiveness, and efficiency of its laboratory network and enhancing its capabilities for research and other laboratory-based scientific and technical activities; addressing US Government Accountability Office (GAO) recommendations that EPA improve cohesion in managing and operating agency laboratories (GAO 2011); and helping the EPA laboratory enterprise¹ respond to change and be equipped to handle emerging scientific challenges (Perciasepe 2013). EPA’s initiative will conclude with the administrator’s guidance on changes to strengthen the laboratory enterprise and its portfolio of physical facilities.

As part of that effort, EPA sought independent expert advice from the National Research Council, which established the Committee on Strengthening the US Environmental Protection Agency Laboratory Enterprise: Phase 1—Priority Needs, Guiding Principles, and Overall Goals. The statement of task (Box 1-1), developed in consultation with EPA, served as a guide for the committee’s work. The committee was asked to assess EPA’s highest-priority needs for mission-relevant laboratory science and technical support, develop principles for the efficient and effective management of EPA’s laboratory enterprise to meet the agency’s mission needs and strategic goals, and develop guidance for enhancing efficiency and effectiveness now and during the next 10 years.

The committee was asked not to assess the organization, the facility-level and portfolio-level master plans, or the consolidation initiatives of EPA’s laboratory enterprise; that analysis is being undertaken in a separate effort. SmithGroupJJR (an architectural and engineering firm) is assisting EPA with the analysis of data collected by EPA on the current portfolio of laboratory facilities. Topics being considered during the analysis include how efficiently facility space is used and the current operating costs of the facilities.² An EPA work group will consider the committee’s input and the results of the separate portfolio-level analysis in developing options for improving the efficiency and effectiveness of EPA’s laboratories, including options for colocation and consolidation. The EPA work group also will recommend an implementation plan for consideration by the EPA administrator and deputy administrator (Paulson 2014). Therefore, the committee was asked not to recommend a reorganization of the laboratory enterprise.

COMMITTEE’S APPROACH TO ITS TASK

At the committee’s first meeting, EPA officials indicated that the committee was not expected to develop a new list of the agency’s highest-priority needs for mission-relevant laboratory science and

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¹“The EPA laboratory enterprise is the aggregate capability and capacity required by its laboratories and laboratory-based centers to meet the agency’s high-priority mission needs of its programs and strategic goals” (Paulson 2013a).

²The results of the portfolio-level analysis were not available to the committee as it was carrying out its study.

technical support but that instead the committee was to assess the highest-priority needs identified previously by EPA on the basis of mission relevance, legislative mandates, and guidance from EPA’s strategic plan, which is revised every 4 years. Therefore the committee considered EPA’s current highest-priority needs to be those associated with major pollution laws administered by the agency and the goals and objectives identified in EPA’s strategic plan. They are described later in this chapter. EPA officials also indicated that the National Research Council report Science for Environmental Protection: The Road Ahead (NRC 2012a) provides a good basis for identifying priorities for the agency for the next 10 years (The priorities identified in that report are provided in this chapter).

Consistent with its statement of task, the committee identified various opportunities where EPA laboratories could become more effective and efficient through a rethinking of its overall system of laboratories. One of the committee’s prime activities was to understand the makeup and function of EPA’s “laboratory enterprise”, which is the subject of the study charge. Although GAO (2011) used the term extensively, there is no readily available guide to how the various types of facilities within the enterprise fit together. In preparing its report, the committee attempted to define the characteristics and dynamics of the enterprise and provide principles and recommendations for its management. It did not attempt to develop principles and recommendations for specific laboratories. Likewise, the committee considered the breadth and complexity of EPA’s highest-priority science needs collectively in developing principles and recommendations for the agency’s laboratory enterprise. The committee did not attempt to develop guidance for meeting specific priority needs individually.

The committee has developed principles and recommendations relevant to aligning laboratory functions with the highest-priority needs, workforce, laboratory equipment, management and leadership, and planning. It considered and built on the relevant findings and recommendations of previous reports from the National Research Council, GAO, and other organizations (see Appendix D). The present report does not address the physical space and configuration options of laboratory facilities, which are being addressed under a contract with SmithGroupJJR. Although there was no opportunity to receive any results of or reports on the work of SmithGroupJJR, it is the committee’s understanding that the firm is not addressing laboratory equipment issues.

Although it is possible that the agency’s laboratory system functions optimally by having each type of laboratory work well on its own, it is the committee’s view that greater efficiency and effectiveness could be gained through systematic collaboration and communication. Based on information provided by EPA, the committee considered the extent to which examples of greater coordination between laboratories appeared to be systematic or ad hoc, and what additional benefits could be achieved by extending the coordination and communication throughout the agency’s laboratory enterprise.

Regarding EPA’s laboratory workforce, the committee recognized that budgetary constraints over the past few years have made it difficult for the agency to hire people with the necessary skills for addressing current and emerging complex problems. The committee examined how tools and programs EPA currently uses, or had used in the recent past, for workforce development could be enhanced. For laboratory equipment, the committee considered where connecting EPA’s processes for managing and acquiring laboratory equipment across the enterprise might present potential opportunities for enhanced efficiency, such as increased sharing of equipment.

Although following the committee’s recommendations may result in efficiency gains that, in turn, may result in lower resource requirements for EPA, the committee realizes that implementing its recommendations is not without cost. However, the committee was not asked to and did not attempt to estimate the implementation costs associated with its recommendations.

THE ENVIRONMENTAL PROTECTION AGENCY’S MISSION

EPA was created in 1970 in response to public alarm and mounting political pressure over degradation of the environment from air, water, and pesticide pollution. Its creation was accomplished by Executive Order 1110.2, which transferred duties related to 15 environmental programs from five departments and one commission to the new agency, whose stated mission was “to protect human health and the environment”. Specifically, EPA’s purpose is to ensure that

• all Americans are protected from significant risks to human health and the environment where they live, learn and work;

• national efforts to reduce environmental risk are based on the best available scientific information;

• federal laws protecting human health and the environment are enforced fairly and effectively;

• environmental protection is an integral consideration in U.S. policies concerning natural resources, human health, economic growth, energy, transportation, agriculture, industry, and international trade, and these factors are similarly considered in establishing environmental policy;

• all parts of society—communities, individuals, businesses, and state, local and tribal governments—have access to accurate information sufficient to effectively participate in managing human health and environmental risks;

• environmental protection contributes to making our communities and ecosystems diverse, sustainable and economically productive; and

• the United States plays a leadership role in working with other nations to protect the global environment.(EPA 2014a).

When it was established, EPA was given statutory authority to provide the regulatory framework for and enforce environmental-pollution laws and to conduct research to support policy development that underpins such efforts. The agency now has responsibility for implementing some 33 laws, congressional mandates, executive orders, and presidential directives. Of those, 10 major federal pollution-control laws drive the bulk of the agency’s activity and budget (Bearden et al. 2007, Table 1-1). The 10 laws are complex to implement, and they create a continuing demand for specific kinds of scientific research and other knowledge that motivate much of the agency’s scientific endeavors (Bearden et al. 2007).

Science underpins the achievement of EPA’s goals by providing information to support a variety of activities from enforcement of current laws and regulations to development of new regulations and identification of threats to public health and the environment. At the time of its creation, EPA was mandated to establish six program offices (some of which were focused on specific environmental media), an assistant administrator to direct the Office of Research and Monitoring (now the Office of Research and Development, ORD), and 10 regional offices whose role was to directly support and interact with the 50 states and territorial and tribal jurisdictions that were responsible for implementing environmental-pollution monitoring, control, enforcement, and cleanup. It “inherited 42 laboratories from programs in various federal departments, including the Department of the Interior; the former Department of Health, Education, and Welfare; and the US Department of Agriculture” (GAO 2011). Although some laboratories have been closed or consolidated since the establishment of EPA, most of the current EPA laboratories remain in the original locations for political, logistic, and other pragmatic reasons. EPA has three general types of laboratories, as discussed below.

THE ENVIRONMENTAL PROTECTION AGENCY LABORATORY ENTERPRISE

EPA’s laboratory enterprise consists of a distributed network of three general types of laboratories, as discussed below.

National Program Office Laboratories

Six laboratories and two centers support five national regulatory program offices—the Office of Air and Radiation (OAR), the Office of Chemical Safety and Pollution Prevention, the Office of Enforcement and Compliance Assurance (OECA), the Office of Water (OW), and the Office of Solid Waste and Emergency Response (OSWER).

National program laboratories have primary responsibility for implementing legislative mandates to develop and provide specific information that supports decisions regarding regulations, compliance, and enforcement at a national level. For example, EPA has been tasked with enforcement of such regulations as vehicle tailpipe-emission regulations and with providing information to the public, such as vehicle mileage performance; the OAR National Vehicle and Fuel Emissions Laboratory performs the motor-vehicle standards and performance testing to provide the needed information. Another OAR laboratory is devoted to assessing radiation risks. Two laboratories in the Office of Chemical Safety and Pollution Prevention support the agency’s pesticide registration and enforcement program. National enforcement efforts are supported by the OECA National Enforcement Investigations Center, which investigates violations of environmental laws and provides technical and forensic services to support for civil and criminal investigations. The center also provides counsel on legal and policy matters.

To augment its intramural analytic capabilities, OSWER contracts with private-sector organizations through the Contract Laboratory Program to carry out laboratory-related activities, primarily to support waste-site remediation projects.

TABLE 1-1 Summary of Major Pollution Laws Administered by EPA

Source: Bearden et al. 2007.

Regional Office Laboratories

Eleven laboratories are distributed among the 10 EPA regional offices—two in Region 3 and one in each of the others. The EPA regions are shown in Figure 1-1. The primary responsibilities of these laboratories include providing scientific data to support decisions by the regions’ environmental programs and to inform immediate and near-term decisions on environmental conditions, compliance, and enforcement. To enforce federal laws and regulations, data on potential violations have to be gathered with legally defensible methods and in accordance with associated quality-assurance procedures. These enforcement actions are typically local and are supported by the network of regional office laboratories. Regional office laboratories also provide technical oversight of work carried out by state agency laboratories, such as assessment of the quality of data that result from drinking-water testing by state laboratories.

Office of Research and Development Laboratories

To improve the basis of the regulations needed to protect public health and environmental quality, it is necessary to improve the scientific understanding of environmental functioning and its interactions with people. ORD laboratories are responsible for performing research and assessing findings developed with support of other agencies and research institutions to provide the basis of standards and regulations and to anticipate emerging threats to health and the environment. ORD consists of seven divisions of the National Health and Environmental Effects Research Laboratory, five divisions of the National Risk Management Research Laboratory, six divisions of the National Exposure Research Laboratory, and six research centers in four national center facilities.

Since 2001, homeland security has also been an important consideration in environmental protection. ORD’s National Homeland Security Research Center, created by a presidential directive after the bioterrorism incidents after 9/11, established the Emergency Response Laboratory Network (ERLN) to respond to, monitor, and remediate incidents of chemical, biologic, and radiologic (CBR) hazard. ERLN is structured as a distributed and virtual laboratory capable of responding to geographically dispersed CBR threat incidents, accidents, and natural disasters in diverse urban and environmental settings. All ORD program and regional laboratories participate in ERLN. The network also encompasses state-based facilities, commercial laboratories, and laboratories and networks of other federal agencies—such as those of the Centers for Disease Control and Prevention, DOE, and the US Department of Agriculture—to achieve critical technical capability, manpower, and concentrated resources to respond to an emergency.

Definition of Laboratory

Given the complex and broad duties of the agency in responding to all its statutory requirements and mandates to meet its mission, it is remarkable that EPA can accomplish its mission within current budget constraints. One indication of its size relative to its mission is that the full-time equivalent allocation to ORD and its budget (not including laboratories in regions or program offices) are roughly equivalent to those of a single, smaller Department of Energy (DOE) national laboratory.

Communications about the size of the laboratory enterprise are often complicated by the fact that different groups in and outside EPA apply different definitions to laboratory. In its communications, EPA does not consistently categorize a laboratory entity among its national program laboratories, its regional office laboratories, and the laboratories, divisions, and centers in the ORD laboratories. Therefore, the discrete components of the laboratory enterprise are not well defined. For the present report, we consider the laboratory enterprise to include the laboratories, divisions, and centers listed in Appendix E.

FIGURE 1-1 EPA regions in the United States. PR and VI in Region 2 refer to Puerto Rico and the Virgin Islands, respectively.

EPA uses the term laboratory in two contexts. One is that of a discrete physical space of a traditional utilitarian research, development, or testing activity that may be devoted to a single technical product or medium-specific activity. The other is that of a large multipurpose structure or collection of structures, perhaps not even in the same location, that focus on a large programmatic theme or a multifaceted research or technology effort. Confounding the designation is that similar entities may be described as centers instead of laboratories, and there appears to be no formal—or at least stated—hierarchic definition of the different entities. That may be due in part to a historical medium-specific function of laboratories inherited at EPA’s formation. It may also be due to an attempt to ascribe functional activities to some facilities that link them to programmatic goals and thrusts of the agency. All this lends a degree of confusion to outside evaluation of the utility, efficiency, and productivity of a unit referred to as a laboratory.

As described above, a degree of semantic confusion leads to different estimates of the number of laboratories that the agency operates. Further confounding the situation is the jumble of acronyms used to refer to the laboratories and their program offices. For instance, the National Air and Radiation Environmental Laboratory in Montgomery, AL (see Appendix E) is also referred to as the National Analytical Radiation Environmental Laboratory, using the same abbreviation (NAREL). To say the least, the morphing of names and abbreviations for laboratories, program offices, and research programs makes for a daunting challenge in following lines of responsibility and goals.

Overall, the committee found that the term laboratory is applied in many circumstances with regard to EPA’s science and technical assistance functions. Moreover, EPA does not clearly define how its laboratories interact. Clear definitions of laboratory and laboratory enterprise are essential. Because of the complexity of EPA’s laboratory enterprise, a single principle might not apply to all aspects of it.

EPA’s laboratory enterprise is part of the larger scientific endeavor within the agency (see Figure 1-2). The larger endeavor is summarized below to provide context for the discussion of the laboratory enterprise in this report.

SCIENCE IN THE ENVIRONMENTAL PROTECTION AGENCY

EPA science entails a wide array of activities, from scientific assessments and reviews to observational and experimental research, modeling, cross-disciplinary synthesis, benefit–cost analysis, and risk analysis. As summarized by the National Research Council Committee on Science for EPA’s Future (NRC 2012a, pp. 107–108), those activities should meet a number of objectives, notably to

• Support the needs of the agency’s regulatory mandates and timetables, informing decisions about regulatory health standards, policies, risk management, emergency response, compliance, and enforcement.

• Identify, build, and maintain the intellectual foundations that will allow the agency to meet current and emerging environmental challenges over the next several decades.

• Set priorities for information and research needs.

• Sustain and continually rejuvenate inhouse research staff and associated laboratories and field capabilities to meet the mission needs of the agency in active collaboration with its partners.

• Appropriately balance inhouse and extramural research investment.

More than 6,000 full-time EPA employees involved in research and other science-related activities are distributed throughout the agency (EPASAB 2012). About 1,450 of them are in ORD, and about 4,700 in program and regional offices. On the basis of information provided by EPA for 2013 (see Appendix E), the laboratory workforce—which includes scientific researchers, technicians, engineers, support staff, and administrative staff in laboratories as opposed to headquarters or program and regional offices—totals roughly 3,630 persons, or about 60% of the agency’s total science workforce. About two-thirds of those are federal personnel (Appendix E).

FIGURE 1-2 The EPA laboratory workforce as a fraction of its total workforce and the national program laboratories, regional office laboratories, and ORD laboratories as fractions of the laboratory workforce (see Appendix E).

Since 1970, EPA has played an important and often a leadership role in advancing many fields of environmental science and engineering, notably ecologic and health sciences, environmental chemistry, environmental monitoring, pollution fate and transport, environmental remediation, ecotoxicology, vehicle efficiency, and emission control. That role has been especially important in generating scientific information that has provided a basis for regulatory decisions (summarized in NRC 2012a). For example, the agency has a long history of leadership in air-pollutant modeling (NRC 2012a); its Community Multiscale Air Quality model is widely used by researchers and agencies in the United States and abroad to model chemical transformations and transport processes of environmental pollutants, such as ground-level ozone, reactive nitrogen, and particulate matter. Since 2006, EPA has maintained a substantial computational-toxicology program whose objective is to develop approaches to the assessment and prediction of toxicity in vitro by using high-throughput testing. EPA scientists have produced new low-cost methods for monitoring landfill gas emissions with laser technology. The agency has advanced the use of molecular tools to track sources of microbial pathogens in surface waters and to set total maximum daily load standards. Similar advances have been made by EPA scientists and engineers in other fields of special relevance to the agency.

The agency’s responsibility for regulation and enforcement creates a unique combination of drivers for its laboratory functions in providing fundamental knowledge and information to inform policy and rules; in establishing robust and defensible analytic methods to support monitoring, certification, and compliance; and in innovation to respond to environmental agents of new concern, forensic needs, terrorism, and natural disasters. Often, the agency’s timetables and manpower staffing are driven by requirements imposed by Congress or the Executive Office of the President.³ Science activities in support of the agency’s regulatory mission are often conducted in the context of important policy-making and decision-making and under public scrutiny. Those factors contribute to a particularly challenging setting in which to build new, long-term science-based initiatives to meet emerging environmental challenges. In addition, tightening budget constraints can exacerbate an inherent tension between the agency’s need to respond to immediate demands for expedited assessments and investigations for regulatory purposes and its longer-term program development to address current and future needs.

ENVIRONMENTAL PROTECTION AGENCY SCIENCE DIRECTIONS AND CHALLENGES

A recent National Research Council report provided a detailed analysis of persistent and emerging environmental challenges for EPA and of the need for new scientific theories and methods that can help to address the challenges (NRC 2012a). Key drivers of environmental change—such as population growth, land conversion, energy and water consumption, consumption of nonfuel materials, and transport of invasive exotic species—have increased considerably over the last 30 years and continue to increase. For example, annual vehicle miles traveled on US highways doubled from around 1.5 trillion miles in 1980 to 3 trillion miles in 2010 (DOT 2012). US nonfuel raw-material consumption (excluding imported goods) increased from 2.19 billion metric tons in 1980 to 3.89 billion metric tons in 2006 before decreasing to 2.57 billion metric tons in 2010 likely as a result of the global financial crisis (Matos 2012). Aggregate emissions of common air pollutants—such as carbon monoxide, lead, nitrogen oxides, volatile organic compounds, particulate matter, and sulfur dioxide—have declined by 63% since 1980 thanks to effective environmental policies, in particular the Clean Air Act (NRC 2012a), but other environmental problems and threats have proved less tractable, and some have increased dramatically (see Box 1-2).

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³See, for example, the Regulatory Flexibility Act or Executive Order 12866 (1993) Regulatory Planning and Review.

Advances in science and engineering and in associated tools and technologies are increasingly important in addressing environmental challenges. For example, improvements in analytic chemistry, advances in chemical fate and transport modeling, and new approaches and technologies for monitoring human exposure to chemicals in the environment are helping to meet the challenge of assessing the effect of human and environmental exposure to chemicals. At the same time, understanding and management of risks associated with those chemicals is changing, thanks to new tools in molecular biology (for example, genomics, proteomics, and metabolomics), such information technologies as bioinformatics, and systems-based approaches for predicting in vivo outcomes on the basis of multiple lines of evidence (NRC 2012a). In the air-pollution arena, coupling of air-quality models with regional atmospheric models is improving short-term forecasting. Models for understanding the interactions between climate change and regional air quality are being developed. Advances in aircraft and satellite remote sensing offer unprecedented opportunities for regional to global air-quality monitoring and prediction. Similar advances are occurring in the water-quality arena, notably in the ability to detect and attribute sources of pathogens and microbial populations in wastewater and surface waters (NRC 2012a). And ever more sophisticated tools in computer science and informatics are revolutionizing data collection (including public engagement), analysis, and reuse and thereby enabling new kinds of data-intensive science and synthesis research (Michener and Jones 2012).

EPA’s ability to address emerging environmental challenges with cutting-edge tools and technologies is strongly conditioned by and intertwined with its role as a regulatory agency. For example, improved detection capabilities would enhance the agency’s capabilities of evaluating the effectiveness of chemical-pollutant regulations (NRC 2004).

STRATEGIC SCIENCE GOALS AND RESOURCE ALLOCATION

To achieve its mission, EPA develops a 4-year strategic plan that defines its goals. In the current strategic plan, EPA outlines the following goals and objectives (EPA, 2014b, Table 1-2):

TABLE 1-2 Goals and Objectives in EPA’s Current Strategic Plan

Source: EPA, 2014b.

Science underpins the achievement of those goals by providing the information needed to support a variety of activities, from the enforcement of current laws and regulations to the development of new regulations and identification of threats to public health and the environment. The alignment of strategic goals and laboratory activities is summarized in Table 1-3. In preparing a budget request, EPA does not provide requests for individual laboratories, types of laboratories, or the entire enterprise. Therefore, it is not apparent from an outsider’s view of the budget how resources given to the agency for its scientific functions correspond with laboratory activities. However, it is apparent that EPA faces a substantial challenge in using available resources to meet all its priority needs for laboratory science and technical support, which may change with factors, such as congressional deadlines, new mandates, changing administrations, and the unknown, such as massive oil spills.

TABLE 1-3 Science Contributions from EPA Laboratories

Source: Paulson 2013b.

Through management, strategic priority-setting, leveraging of resources with stakeholders and other agencies, and the work of committed professionals, the agency has built a laboratory-science capability in support of its mission. Whether it can maintain that status, respond to future environmental threats, and continue to protect the public health remains an open question in light of the current budget climate. For example, the agency operates in a climate of shrinking resources, which results in great reduction in the ability to make up for the loss of seasoned personnel.

ORGANIZATION OF THE REPORT

The committee’s work required considerations at the intersection of diverse fields, including environmental program design and management; toxicology; environmental medicine; environmental health; engineering; environmental law; environmental policy, regulation, and risk management; and ecologic and health risk assessment. The following chapters provide some brief, fundamental background on those topics as a basis for discussions and recommendations. The committee’s charge was to develop principles for the efficient and effective management of EPA’s laboratory enterprise to meet the agency’s mission needs and strategic goals in the present and during the next 10 years. Chapter 2 provides an analytic framework in which EPA can efficiently and effectively deliver the scientific outputs that will contribute to health and environmental protection outcomes. Chapter 3 identifies summary principles of a high-quality laboratory enterprise and focuses specifically on the workforce and equipment. Although physical facilities constitute a critical element of a laboratory system, that aspect is being addressed in a separate effort, as discussed above. In Chapter 4, the committee addresses the management processes that would help to tie the enterprise together, focusing on planning, implementation, assessment, and communication within EPA. Chapter 5 discusses approaches for identifying emerging challenges, and Chapter 6 presents all the principles identified in this report and links them to the committee’s recommendations.